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FDA 510(k)

BIS MODULE FOR ENVOY PATIENT MONITOR

K-Number: K071899 · 2007-10-22

ApplicantMennen Medical , Ltd.
Decision Date2007-10-22
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS MODULE FOR ENVOY PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical , Ltd.. It received FDA 510(k) clearance on 2007-10-22 under 510(k) number K071899. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIS MODULE FOR ENVOY PATIENT MONITOR?

BIS MODULE FOR ENVOY PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2007-10-22. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K071899.

When did BIS MODULE FOR ENVOY PATIENT MONITOR receive FDA 510(k) clearance?

BIS MODULE FOR ENVOY PATIENT MONITOR received FDA 510(k) clearance on 2007-10-22, under 510(k) number K071899.

Who is the listed applicant for BIS MODULE FOR ENVOY PATIENT MONITOR?

The FDA 510(k) record lists Mennen Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIS MODULE FOR ENVOY PATIENT MONITOR?

The FDA product code for BIS MODULE FOR ENVOY PATIENT MONITOR is OLW.

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Other records listing Mennen Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131789CEREBRALOGIK- AEEGK123792HORIZON XVU (FFR)K093766VITALOGIK 6000/6500K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVU

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Related Devices (Code: OLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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